CDS Medical Decision Support Systems

2025: GOST for AI-system of medical decision-making approved in Russia

At the end of October 2025, GOST R 72313-2025 "Systems for supporting medical decision-making using artificial intelligence to extract data from unstructured medical records was approved in Russia. Methods for generating a dataset for training and testing. Quality assessment metrics. " Read more here.

2017: Draft FDA Guidance

On December 11, 2017, the United States Food and Drug Administration (FDA) issued a new draft guideline for evaluating medical devices and physician decision support systems (CDS) in response to changes in relevant regulations.

Under amendments in federal law passed in December 2017, some software features were removed from the definition of "medical devices," and therefore no longer subject to FDA oversight. These changes are incorporated into the new draft guidance.

Draft guidance created for IT systems to support medical decision-making

Devices designed solely for transmission, storage, format conversion, or display of medical examination data and results are no longer medical devices and must not meet FDA requirements. However, programs that analyze or interpret medical data remain under regulatory oversight by the FDA. This amendment will probably not be of great practical importance, since the FDA back in 2015 abandoned increased control over such devices.

The regulator's document also contains updates on mobile medical applications. Now mobile applications that display medical images learned directly from the image transmission and archiving system fall under the selective application of the law, that is, the FDA decides at its discretion when it will resort to appropriate enforcement measures. All mobile applications that are not designed for diagnostic image analysis are now not considered medical devices.

The amendments also affected the systems for supporting medical decision-making. The programs used to prescribe imaging studies now do not fall under the definition of a medical device and are no longer under FDA control. However, programs designed to receive, process, or analyze medical images/signal from the diagnostic system will continue to be treated as medical devices and must meet FDA requirements.^[1]

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